Device recall
Z-1524-2009: Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System)…
FDA device recall · Class II · Ascension Orthopedics, Inc
Key facts
| Recall number (Z-number) | Z-1524-2009 |
|---|---|
| Recall event | 52031 |
| Product | Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver. |
| Product code | HXX |
| Recalling firm | Ascension Orthopedics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2010 |
| 510(k) numbers | K022324, K022325 |
| FEI number | 3002788818 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database